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Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04147858
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx

Brief Summary:
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: NYX-2925 Drug: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.

This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week double-blind, randomized, placebo-controlled Treatment Period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: NYX-2925 50 mg
NYX-2925 50 mg administered orally.
Drug: NYX-2925
NYX-2925 administered orally

Experimental: NYX-2925 100 mg
NYX-2925 100 mg administered orally.
Drug: NYX-2925
NYX-2925 administered orally

Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Placebo administered orally




Primary Outcome Measures :
  1. Change in the mean Numerical Rating Scale (NRS) score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 ]
    Percentage of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12

  2. Daily Sleep Interference (DSIS) score [ Time Frame: Week 12 ]
    Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12

  3. Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Week 12 ]
    Percentage of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12

  4. Percentage of subjects achieving ≥50% pain reduction [ Time Frame: Week 12 ]
    Percentage of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12

  5. Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score

  6. Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) sleep disturbance score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score

  7. Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) fatigue profile score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the PROMIS-FM fatigue profile score

  8. Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) physical function score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the PROMIS-FM physical function score

  9. Cumulative response (percent reduction from baseline) in weekly mean NRS [ Time Frame: Week 12 ]
    Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12

  10. Use of rescue medication [ Time Frame: Week 12 ]
    Use of rescue medication, including the proportion of subjects using rescue medication, the frequency and amount used

  11. Change in the mean NRS score at each week [ Time Frame: Week 1 - Week 12 ]
    Change from baseline in the weekly mean of the daily Numerical Rating Scale (NRS) at each week from Week 1 through Week 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Informed consent
  • Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week
  • Stable protocol allowed medication and other therapies during the study
  • Agrees to use highly effective birth control during the study
  • Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

  • Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
  • Current or historical serious medical conditions
  • Prior participation in NYX-2925 clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147858


Contacts
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Contact: Aptinyx Clinical Development 847 871 0377 ext 1 clinicalstudies@aptinyx.com

Locations
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Sponsors and Collaborators
Aptinyx
Worldwide Clinical Trials
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Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04147858    
Other Study ID Numbers: NYX-2925-2005
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases